In a risk-based inspection (RBI), Schedule M – Point 2.4 (Quarantine controls in warehouse/store) is assessed as a critical “quality gate” because quarantine is the main barrier preventing unreleased/untested materials or products from entering manufacturing or dispatch.
What Point 2.4 requires: If quarantine status is ensured by warehousing in separate earmarked areas within the same warehouse/store, those areas must be clearly demarcated. If a system replaces physical quarantine, it must provide equivalent assurance of segregation. Access to quarantine areas must be restricted to authorized persons.
How inspectors test compliance (RBI approach)
1) “Trace one lot” challenge: Inspectors select a recent RM/PM/FG lot and trace receipt → quarantine → sampling → QC testing → QA release → issuance/dispatch. Any pathway that allows issuing or dispatching while still “quarantine/under test” is treated as a high-severity gap. CDSCO
2) Physical demarcation effectiveness: They verify quarantine is not only a board/paint line. They look for physical separation (cage/partition/marked bays), clear status labels, defined movement routes, and prevention of “temporary parking” of quarantine materials in released areas—especially for look-alike packs and multi-strength products.
3) “System quarantine” equivalence (if used): RBI checks whether ERP/WMS has robust blocks: barcode scanning, system lock preventing picking/issuing, audit trails for status change, and QA-only authorization for release. Inspectors compare system status vs physical location to detect mismatches.
4) Restricted access control: Inspectors confirm controlled entry (locks, access logs, key control) and that only authorized roles can enter quarantine or change status.
Common RBI red flags: mixed quarantine and released stock, shared keys, manual overrides without audit trail, and repeated wrong-issue deviations without effective CAPA.